Bioequivalence and Bioavailability Forum

Dear All,

This is regarding Orlistat for EMA submission. We have US product specific guidance available but I am unable to find EMA guidance (most probably its not there).

My question is whether is it required to add third arm (The reference product at 2 x 60 mg or 120 mg tid) as per US OGD for EMA? whether regualotry will accept this design as per FDA or 2WCO is sufficient (The test & reference product at 60 mg tid as crossover)?

thanks.